Step

Operation

Reference Images

 1

Sample Preparation

• For swab samples: Insert the swab into the reconstitution solution tube, rotate 10 times to fully elute the sample. Remove and discard the swab.

• For urine samples: Add 5 μL of urine into the reconstitution solution tube and mix well.

 2

Reconstitute LAMP Lyophilized Bead

Invert the reconstitution solution tube containing the sample, squeeze and add 2 drops (approximately 100 μL) of reconstitution solution into the LAMP reaction tube to dissolve the lyophilized bead.

 3

Isothermal Amplification

Turn on the heater and set to 65°C. After the temperature stabilizes, place the reaction tube from Step 2 into the heater with the bottom end facing down. Incubate for 15 minutes.

 4

Sample Dilution 

Remove the reaction tube from the heater. Squeeze the reconstitution solution tube to add all the liquid (approximately 8 drops) into the LAMP reaction tube. Gently shake the reaction tube to mix thoroughly.

 5

Mount Test Device

Insert the test device into the sample applicator until it fits securely. Ensure the device is aligned correctly.

 6

Sample Application

Insert the reaction tube from Step 4 into the sample applicator and rotate it one full turn. The applicator will pierce the bottom of the LAMP reaction tube, allowing the liquid to flow onto the sample pad of the test device. The liquid will migrate along the test device via capillary action. Start timing immediately.

 7

Result Interpretation

Read the test result at 5 minutes. Do not read the result after 10 minutes.

8

Disposal
After testing, place the entire assembly into a biohazard bag and discard it in a biohazard waste container. Do not open or disassemble any component, as this may release aerosols and cause contamination.